The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in COPD Patients Awaiting Lung Transplantation

June 25, 2020 updated by: Klaus Kenn

The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease Awaiting Lung Transplantation

Data from chronic obstructive pulmonary disease patients awaiting lung transplantation which performed a pulmonary rehabilitation program will be analyzed retrospectively. Acute exacerbations occur frequently in these patients and have a major impact on the course of the disease. This study investigates the prevalence and the impact of acute exacerbations during pulmonary Rehabilitation in patients with severe chronic obstructive pulmonary disease patients awaiting lung Transplantation that continued the Rehabilitation program despite an acute exacerbation. Data will be taken from the internal database of the reference center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where these data were collected during clinical routine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

559

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schönau Am Königssee, Germany, 83471
        • Schoen Klinik Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

data will be collected from the internal database of the reference Center

Description

Inclusion Criteria:

  • confirmed diagnosis of chronic obstructive pulmonary disease including patients with alpha-1 antitrypsin deficiency
  • listed for lung Transplantation or in the Evaluation process for lung transplantation
  • performed a pulmonary rehabilitation program at the reference center

Exclusion Criteria:

  • patients that discontinued the pulmonary Rehabilitation program due to any reason and could therefore not perform assessement tests at the end of regular Rehabilitation program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with an acute exacerbation during Rehabilitation
Patients with severe chronic obstructive pulmonary disease awaiting lung Transplantation that developed an acute exacerbation during a pulmonary Rehabilitation program but continued the Rehabilitation program
Other: Pulmonary Rehabilitation
Patients performed a comprehensive pre-lung transplant inpatient pulmonary rehabilitation program for 4 to 5 weeks duration.
patients without an acute exacerbation during Rehabilitation
Patients with severe chronic obstructive pulmonary disease awaiting lung Transplantation that did not develop an acute exacerbation during a pulmonary Rehabilitation program and completed the Rehabilitation program regularly.
Other: Pulmonary Rehabilitation
Patients performed a comprehensive pre-lung transplant inpatient pulmonary rehabilitation program for 4 to 5 weeks duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-minute walk distance
Time Frame: day 1 and last day of pulmonary rehabilitation
The 6-minute walk test will be performed in accordance to the Guidelines of the European Respiratory Society and the American Thoracic Society
day 1 and last day of pulmonary rehabilitation
Change in Quality of life
Time Frame: day 1 and last day of pulmonary rehabilitation
health-related Quality of life will be assessed by the physical and mental health component score of the short form 36 health survey (score from 0 to 100 with higher scores indicating better quality of life)
day 1 and last day of pulmonary rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klaus Kenn

Collaborators

Schön Klinik Berchtesgadener Land

Investigators

  • Principal Investigator: Rembert A Koczulla, MD, Schoen Klinik Berchtesgadener Land

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2020

Primary Completion (Actual)

May 10, 2020

Study Completion (Actual)

May 10, 2020

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AECOPD pre-LTX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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